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FDF Dossiers

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Jai Radhe Sales is your partner for all your sourcing needs.

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xyz-pharma-m-2024-10-07

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Padagis

VISIT THE VIRTUAL BOOTH, Contact Details

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EVENTS

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DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 41 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
41 NEWS #PharmaBuzz

DEVELOPMENTS

13 Drugs in Development

13 Drugs in Development

FINISHED DOSAGE FORMULATIONS

190 FDF Dossiers, 190 FDA Orange Book

190 FDF Dossiers
190 FDA Orange Book

INSPECTIONS & REGISTRATIONS

12 FDA, 2 GDUFA

12 FDA
2 GDUFA

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FILTER :

filter Active Ingredients Reset all filters

190 All

01 2ACYCLOVIR

02 2ADAPALENE; BENZOYL PEROXIDE

03 1ALBUTEROL SULFATE

04 1AMILORIDE HYDROCHLORIDE

05 2AMMONIUM LACTATE

06 2AZELASTINE HYDROCHLORIDE

07 1AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

08 1BACITRACIN

09 1BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

10 1BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

11 1BACITRACIN ZINC; POLYMYXIN B SULFATE

12 4BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

13 4BETAMETHASONE DIPROPIONATE

14 2BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

15 1BETAMETHASONE VALERATE

16 1BRIMONIDINE TARTRATE

17 1BRINZOLAMIDE

18 1BROMOCRIPTINE MESYLATE

19 1BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

20 2BUDESONIDE

21 2BUTOCONAZOLE NITRATE

22 1CALCIUM ACETATE

23 1CETIRIZINE HYDROCHLORIDE

24 1CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

25 5CICLOPIROX

26 1CLINDAMYCIN PALMITATE HYDROCHLORIDE

27 8CLINDAMYCIN PHOSPHATE

28 5CLOBETASOL PROPIONATE

29 1CLOTRIMAZOLE

30 1CYANOCOBALAMIN

31 1CYCLOSPORINE

32 2DAPSONE

33 2DESONIDE

34 4DESOXIMETASONE

35 1DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

36 1DEXAMETHASONE; TOBRAMYCIN

37 1DICLOFENAC SODIUM

38 1DIHYDROERGOTAMINE MESYLATE

39 1ECONAZOLE NITRATE

40 1EFINACONAZOLE

41 4ERYTHROMYCIN

42 7ESTRADIOL

43 1FLAVOXATE HYDROCHLORIDE

44 3FLUOCINOLONE ACETONIDE

45 2FLUOCINONIDE

46 1FLURANDRENOLIDE

47 3FLUTICASONE PROPIONATE

48 3GENTAMICIN SULFATE

49 4HALOBETASOL PROPIONATE

50 1HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

51 1HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

52 4HYDROCORTISONE

53 1HYDROCORTISONE VALERATE

54 4HYDROMORPHONE HYDROCHLORIDE

55 1IBUPROFEN

56 1IMIQUIMOD

57 2INGENOL MEBUTATE

58 1IVERMECTIN

59 2KETOCONAZOLE

60 1LEVOCETIRIZINE DIHYDROCHLORIDE

61 1LIDOCAINE; PRILOCAINE

62 1LOTEPREDNOL ETABONATE

63 1MESALAMINE

64 1METRONIDAZOLE

65 1MIDAZOLAM HYDROCHLORIDE

66 2MOMETASONE FUROATE

67 1MORPHINE SULFATE

68 2MUPIROCIN

69 1MUPIROCIN CALCIUM

70 1NALOXONE HYDROCHLORIDE

71 2NARATRIPTAN HYDROCHLORIDE

72 1NITROGLYCERIN

73 3NYSTATIN

74 2NYSTATIN; TRIAMCINOLONE ACETONIDE

75 1OLOPATADINE HYDROCHLORIDE

76 1PENCICLOVIR

77 1PERMETHRIN

78 1PILOCARPINE HYDROCHLORIDE

79 2PODOFILOX

80 4POTASSIUM CHLORIDE

81 1PROCHLORPERAZINE

82 2PROMETHAZINE HYDROCHLORIDE

83 3REPAGLINIDE

84 1SCOPOLAMINE

85 1SELENIUM SULFIDE

86 2SULFACETAMIDE SODIUM

87 2SUMATRIPTAN

88 1TAVABOROLE

89 3TAZAROTENE

90 1TERCONAZOLE

91 4TESTOSTERONE

92 1TESTOSTERONE CYPIONATE

93 5TRETINOIN

94 8TRIAMCINOLONE ACETONIDE

95 1TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)

96 2TROSPIUM CHLORIDE

97 2ZOLMITRIPTAN

filter Applicant Reset all filters

190 All

01 90PADAGIS ISRAEL

02 100PADAGIS US

filter Dosage Form Reset all filters

190 All

01 1AEROSOL, FOAM;RECTAL

02 6AEROSOL, FOAM;TOPICAL

03 1AEROSOL, METERED;INHALATION

04 1CAPSULE, DELAYED RELEASE;ORAL

05 3CAPSULE, EXTENDED RELEASE;ORAL

06 1CREAM, AUGMENTED;TOPICAL

07 27CREAM;TOPICAL

08 5CREAM;VAGINAL

09 1ENEMA;RECTAL

10 1FOR SOLUTION;ORAL

11 1GEL, METERED;TRANSDERMAL

12 23GEL;TOPICAL

13 7GEL;TRANSDERMAL

14 1GEL;VAGINAL

15 3INJECTABLE;INJECTION

16 1LOTION/SHAMPOO;TOPICAL

17 10LOTION;TOPICAL

18 1OIL/DROPS;OTIC

19 2OIL;TOPICAL

20 1OINTMENT, AUGMENTED;TOPICAL

21 7OINTMENT;OPHTHALMIC

22 18OINTMENT;TOPICAL

23 1POWDER;TOPICAL

24 3SHAMPOO;TOPICAL

25 1SOLUTION, METERED;TRANSDERMAL

26 1SOLUTION/DROPS;OPHTHALMIC

27 5SOLUTION;ORAL

28 7SOLUTION;TOPICAL

29 6SPRAY, METERED;NASAL

30 1SPRAY, METERED;SUBLINGUAL

31 4SPRAY;NASAL

32 3SPRAY;TOPICAL

33 1SPRAY;TRANSDERMAL

34 3SUPPOSITORY;RECTAL

35 1SUPPOSITORY;VAGINAL

36 3SUSPENSION/DROPS;OPHTHALMIC

37 1SUSPENSION;ORAL

38 2SUSPENSION;TOPICAL

39 3SWAB;TOPICAL

40 3SYRUP;ORAL

41 1SYSTEM;TRANSDERMAL

42 6TABLET, EXTENDED RELEASE;ORAL

43 11TABLET;ORAL

44 1TROCHE/LOZENGE;ORAL

filter Dosage Reset all filters

190 All

01 10.005%

02 50.01%

03 10.015%

04 40.025%

05 210.05%

06 20.064%;0.005%

07 70.1%

08 10.1% (0.25GM/PACKET)

09 10.1% (0.5GM/PACKET)

10 10.1% (0.75GM/PACKET)

11 10.1% (1.25GM/PACKET)

12 10.1% (1GM/PACKET)

13 10.1%;0.3%

14 10.1%;2.5%

15 10.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

16 10.12%

17 10.137MG/SPRAY;0.05MG/SPRAY

18 10.147MG/GM

19 20.2%

20 20.2055MG/SPRAY

21 30.25%

22 10.3%;2.5%

23 10.4MG/SPRAY

24 50.5%

25 10.5MG

26 10.5MG/SPRAY

27 10.665MG/SPRAY

28 10.75%

29 30.77%

30 71%

31 11.53MG/SPRAY

32 11.5MG/5ML;5MG/5ML

33 11.62% (20.25MG/1.25GM ACTUATION)

34 11.62% (20.25MG/1.25GM PACKET)

35 11.62% (40.5MG/2.5GM PACKET)

36 310%

37 3100,000 UNITS/GM

38 2100,000 UNITS/GM;0.1%

39 1100MG

40 2100MG/5ML

41 210MEQ

42 110MG

43 112.5MG

44 112MG

45 116MG

46 11MG

47 11MG/72HR

48 11MG/ML

49 92%

50 42.5%

51 12.5%;2.5%

52 12.5%;EQ 1.2% BASE

53 12.5MG/5ML

54 12.5MG/SPRAY

55 1200MG/ML

56 120MG

57 120MG/SPRAY

58 225MG

59 12MG

60 12MG/5ML;10MG/5ML;30MG/5ML

61 12MG/ACTUATION

62 13%

63 13.7%;2.86%;3.42%

64 13.75%;EQ 1.2% BASE

65 130MG/1.5ML ACTUATION

66 132MG

67 13MG

68 1400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

69 1400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

70 14GM/60ML

71 14MG/5ML;5MG/5ML;60MG/5ML

72 14MG/SPRAY

73 65%

74 15%;1.2%

75 15%;EQ 1% BASE

76 1500 UNITS/GM

77 1500 UNITS/GM;10,000 UNITS/GM

78 150MG/ML

79 25MG

80 15MG/5ML

81 15MG/5ML;60MG/5ML

82 25MG/SPRAY

83 160MG

84 1667MG

85 17.5%

86 18%

87 180MG

88 28MEQ

89 18MG

90 4EQ 0.05% BASE

91 1EQ 0.09MG BASE/INH

92 2EQ 0.1% BASE

93 1EQ 0.3% BASE

94 1EQ 0.33% BASE

95 6EQ 1% BASE

96 2EQ 12% BASE

97 1EQ 1MG BASE

98 2EQ 2% BASE

99 2EQ 2.5MG BASE

100 1EQ 2MG BASE/ML

101 1EQ 75MG BASE/5ML

filter Country Reset all filters

190 All

01 190USA

List of Suppliers

Supplier Virtual Booth

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01

Brand Name : ACYCLOVIR

BMWS24

Not Confirmed

Brand Name : ACYCLOVIR

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Regulatory Info : DISCN

Registration Country : USA

Dosage Form : OINTMENT;TOPICAL

Brand Name : ACYCLOVIR

Dosage Strength : 5%

Packaging :

Approval Date : 2019-02-20

Application Number : 205659

Regulatory Info : DISCN

Registration Country : USA

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02

Brand Name : ACYCLOVIR

BMWS24

Not Confirmed

Brand Name : ACYCLOVIR

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Regulatory Info : RX

Registration Country : USA

Dosage Form : CREAM;TOPICAL

Brand Name : ACYCLOVIR

Dosage Strength : 5%

Packaging :

Approval Date : 2019-02-04

Application Number : 208702

Regulatory Info : RX

Registration Country : USA

Product
Web Link

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03

Brand Name : ADAPALENE AND BENZOY...

BMWS24

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Brand Name : ADAPALENE AND BENZOY...

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Regulatory Info : RX

Registration Country : USA

ADAPALENE; BENZOYL PEROXIDE

Dosage Form : GEL;TOPICAL

Brand Name : ADAPALENE AND BENZOYL PER...

Dosage Strength : 0.1%;2.5%

Packaging :

Approval Date : 2018-01-23

Application Number : 205033

Regulatory Info : RX

Registration Country : USA

Product
Web Link

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04

Brand Name : ADAPALENE AND BENZOY...

BMWS24

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Brand Name : ADAPALENE AND BENZOY...

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Regulatory Info : RX

Registration Country : USA

ADAPALENE; BENZOYL PEROXIDE

Dosage Form : GEL;TOPICAL

Brand Name : ADAPALENE AND BENZOYL PER...

Dosage Strength : 0.3%;2.5%

Packaging :

Approval Date : 2022-05-31

Application Number : 212464

Regulatory Info : RX

Registration Country : USA

Product
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05

Brand Name : ALBUTEROL SULFATE

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Brand Name : ALBUTEROL SULFATE

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Regulatory Info : DISCN

Registration Country : USA

ALBUTEROL SULFATE

Dosage Form : AEROSOL, METERED;INHALAT...

Brand Name : ALBUTEROL SULFATE

Dosage Strength : EQ 0.09MG BASE/INH

Packaging :

Approval Date : 2020-02-24

Application Number : 203760

Regulatory Info : DISCN

Registration Country : USA

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06

Brand Name : MIDAMOR

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Brand Name : MIDAMOR

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Regulatory Info : RX

Registration Country : USA

AMILORIDE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Brand Name : MIDAMOR

Dosage Strength : 5MG

Packaging :

Approval Date : 1982-01-01

Application Number : 18200

Regulatory Info : RX

Registration Country : USA

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07

Brand Name : AMMONIUM LACTATE

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Brand Name : AMMONIUM LACTATE

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Regulatory Info : RX

Registration Country : USA

AMMONIUM LACTATE

Dosage Form : LOTION;TOPICAL

Brand Name : AMMONIUM LACTATE

Dosage Strength : EQ 12% BASE

Packaging :

Approval Date : 2004-06-23

Application Number : 75570

Regulatory Info : RX

Registration Country : USA

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08

Brand Name : AMMONIUM LACTATE

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Brand Name : AMMONIUM LACTATE

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Regulatory Info : RX

Registration Country : USA

AMMONIUM LACTATE

Dosage Form : CREAM;TOPICAL

Brand Name : AMMONIUM LACTATE

Dosage Strength : EQ 12% BASE

Packaging :

Approval Date : 2002-05-01

Application Number : 75774

Regulatory Info : RX

Registration Country : USA

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09

Brand Name : AZELASTINE HYDROCHLO...

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Brand Name : AZELASTINE HYDROCHLO...

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Regulatory Info : DISCN

Registration Country : USA

AZELASTINE HYDROCHLORIDE

Dosage Form : SPRAY, METERED;NASAL

Brand Name : AZELASTINE HYDROCHLORIDE

Dosage Strength : 0.2055MG/SPRAY

Packaging :

Approval Date : 2014-05-08

Application Number : 202743

Regulatory Info : DISCN

Registration Country : USA

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10

Brand Name : AZELASTINE HYDROCHLO...

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Brand Name : AZELASTINE HYDROCHLO...

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Regulatory Info : DISCN

Registration Country : USA

AZELASTINE HYDROCHLORIDE

Dosage Form : SPRAY, METERED;NASAL

Brand Name : AZELASTINE HYDROCHLORIDE

Dosage Strength : 0.2055MG/SPRAY

Packaging :

Approval Date : 2024-05-08

Application Number : 216801

Regulatory Info : DISCN

Registration Country : USA

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